(61 days)
The BIS/EEG Module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BIS/EEG Module is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.
The BIS/EEG Module is intended to monitor the Bispectral Index (BIS), a processed EEG variable which may be used as an aid in monitoring the effects of certain anesthetic agents.
The BIS/EEG Module is part of a modular system used to monitor the state of the brain by data acquisition of EEG signals. The module is also used as an aid in monitoring the effects of certain anesthetic agents using Aspect's Bispectral Index® parameter.
BIS/EEG Module works as a component of a GE Medical Systems Information Technologies host monitoring system and does not function on its own. The BIS/EEG Module provides information obtained from the sensors/electrodes to the bedside monitor for display.
The provided document is a 510(k) summary for the BIS/EEG Module, declaring substantial equivalence to a predicate device, rather than a study report detailing specific acceptance criteria and performance metrics for the device itself. Therefore, many of the requested details are not present in this document.
Here's what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Explanation: The document states that "The BIS/EEG Module and its host patient monitoring system comply with the voluntary standards as detailed in Section 9 of this submission." However, Section 9 (which would detail these standards and associated acceptance criteria) is not provided in the given excerpt. Without Section 9, specific numerical or qualitative acceptance criteria and reported performance values related to those criteria are not available. The conclusion simply states that the module "is as safe, as effective, and perform as well as the predicate device," which is a general statement of substantial equivalence, not a detailed performance report against specific criteria.
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This information would be relevant to studies involving human interpretation or clinical outcomes, which are not detailed here. The focus of this 510(k) summary is on technical performance relative to a predicate device.
4. Adjudication method for the test set:
- Not applicable for the information provided.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
- Not applicable. This device is an Electroencephalograph (EEG) module that monitors brain state and the effects of anesthetic agents by processing EEG signals. It's a sensor/processing unit, not an AI-assisted diagnostic tool that human readers would use to improve their interpretation of images or other subjective data. Therefore, an MRMC study in this context is unlikely or not relevant based on the described intended use.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document describes "Testing on unit level (Module verification)" and "Integration testing (System verification)", which imply standalone and integrated performance testing of the device's algorithms and hardware. However, specific details of these tests, including the metrics and results of such standalone performance, are not provided. The phrase "algorithm only" may not be entirely appropriate as this is a hardware and software system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. Given the nature of an EEG module, ground truth for performance testing would likely involve established physiological measurements or simulated signals to verify accuracy and precision, but no specifics are provided in this summary.
8. The sample size for the training set:
- Not applicable. The document does not describe the development of a machine learning or AI model that would typically involve a "training set." The device "employs the same functional scientific technology as its predicate device," suggesting an established technology rather than a newly trained algorithm.
9. How the ground truth for the training set was established:
- Not applicable (see point 8).
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OCT - 1 2001
K012466
102
Section 2 Summary and Certification
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| Date: | July 31, 2001 |
| Submitter: | GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA |
| Contact Person: | Karen WebbSr. Regulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: (414) 382-3329Fax: (414) 918-8114 |
| Device: Trade Name: | BIS/EEG Module |
| Common/Usual Name: | Electroencephalograph (EEG) |
| Classification Names: | 21 CFR 882.1400 Electroencephalograph |
| Predicate Devices: | K974496, K923043 & K011843 Aspect Medical Systems, Inc. EEGMonitor with BIS Engine |
| Device Description: | The BIS/EEG Module is part of a modular system used to monitor thestate of the brain by data acquisition of EEG signals. The module isalso used as an aid in monitoring the effects of certain anestheticagents using Aspect's Bispectral Index® parameter. |
| BIS/EEG Module works as a component of a GE Medical SystemsInformation Technologies host monitoring system and does not functionon its own. The BIS/EEG Module provides information obtained fromthe sensors/electrodes to the bedside monitor for display. | |
| Intended Use: | The BIS/EEG Module is intended for use under the direct supervision ofa licensed healthcare practitioner or by personnel trained in its properuse. The BIS/EEG Module is intended for use on adult and pediatricpatients within a hospital or medical facility providing patient care tomonitor the state of the brain by data acquisition of EEG signals. |
| The BIS/EEG Module is intended to monitor the Bispectral Index (BIS),a processed EEG variable which may be used as an aid in monitoringthe effects of certain anesthetic agents. | |
| Technology: | The BIS/EEG Module employs the same functional scientific technologyas its predicate device. |
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K012466
21F2
Test Summary:
The BIS/EEG Module and its host patient monitoring system comply with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the BIS/EEG Module:
- Risk Analysis .
- . Requirements Reviews
- Design Reviews �
- Testing on unit level (Module verification) ●
- Integration testing (System verification) .
- Final acceptance testing (Validation) .
- . Performance testing
- Safety testing .
- Environmental testing .
Conclusion:
The results of these measurements demonstrated that the BIS/EEG Module is as safe, as effective, and perform as well as the predicate device.
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Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features an abstract image of an eagle with its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Karen Webb Senior Regulatory Affairs Specialist GE medical Systems Information Technologies 8200 West Tower Avenue Milwaukee, Wisconsin 53223
Re: K012466
Trade/Device Name: BIS/EEG Module Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, OLT, ORT, OMC Dated (Date on orig SE Itr): July 31, 2001 Received (Date on orig SE ltr): August 1, 2001
Dear Ms. Webb:
This letter corrects our substantially equivalent letter of October 1, 2001.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
APR - 9 2012
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
for
Sincerely vours.
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
K012466; 510(k) filed on July 31, 2001 510(k) Number (if known):
BIS/EEG Module Device Name:
Indications for Use:
The BIS/EEG Module is intended for use under the direct supervision of a licensed healthcare The BIS/ECG Module is microod in to proper use. The BIS/EEG Module is intended for use on precidents of by personner delitor in to pioper receivel facility providing patient cafe to monitor the state of the brain by data acquisition of EEG signals.
The BIS/EEG Module is intended to monitor the Bispectrail Index (BIS), a processed EEG variable which may be used as an aid in monitoring the effects of certain anesthetic agents.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
for Mark n Melleus
al. Restorative
510(k) Number K 012466
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).